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We have vacancies for a Junior Office Assistant, a Clinical Lead and a Regulatory Affairs Director

Blueberry’s vision is to bring high value, innovative medicines to the market that make a real difference to patients’ lives. We are now growing, and looking for a full time Junior Office Assistant, a Clinical Lead and a Regulatory Affairs Director to join our successful team. If you have the skills listed below, enjoy working in a dynamic, exciting environment, and really want to have a positive impact on patients’ lives, then we’d love to hear from you.

To recruitment companies: any unsolicited emails, phone calls or CVs will not be acknowledged.


Junior Office Assistant

Blueberry Therapeutics are seeking an enthusiastic Junior Office Assistant to join our team. The role will be full time and office-based.

Summary:

The Junior Office Assistant represents the company in a professional manner at all times and assists the Office Manager in the smooth running of the office by providing high quality administrative support. The Junior Office Assistant reports to the Office Manager and will also provide administrative support to the Blueberry team.

Tasks & responsibilities:

  • Providing general administrative support to the Office Manager and to the wider team by scanning documents, filing etc
  • Ensuring offices are maintained, e.g. arranging maintenance staff to clean office/carry out repairs
  • Ordering office consumables
  • Tracking employee information e.g. annual leave
  • Organising team diaries and arranging meetings/business events
  • Booking domestic and international travel, creating travel itineraries
  • Managing electronic and paper filing systems
  • Hosting visitors
  • Attending training courses and conferences as required

Requirements:

  • Educated to GCSE level, including English, maths and science
  • Be able to demonstrate exceptional organisational skills
  • A real team player
  • Motivated and proactive
  • Thorough, with a real eye for detail
  • Good communication skills
  • Computer literate – experience in MS Office packages such as Word, Powerpoint, Excel and Outlook an advantage, though training will be provided

To apply, please email your CV and covering letter to susan.yau@blueberrytherapeutics.com

Salary: from £15,500 to £18,000 per annum dependant on experience.

Closing date: 5th April 2019


Clinical Lead

Summary:

The Clinical Lead will serve as the medical expert for assigned clinical trials and will provide input into the design and conduct of clinical trials, assessment and interpretation of safety data, and contribute to investigator training to secure safety and well-being of clinical research participants.

Tasks & Responsibilities:

  • Protocol development and consulting with functions such as BioStats, Preclinical, Regaultory, QA, and the Exec team during protocol development
  • Serve as the in-house subject matter expert and consult other groups as needed for decision-making
  • Therapeutic training and consulting
  • Medical review of informed consent and CRF design, clinical trial protocol and Investigator Brochure
  • Development of individual study medical monitoring plans
  • Site selection and enrolment enhancement solutions
  • Key opinion leader network development
  • Scientific and medical support for project management teams and sites
  • Subject Listing and Laboratory data review
  • Medical data coding and review
  • 24-hour on call medical monitoring for protocol queries and site support, medical/safety issues
  • Regulatory agency support and interface
  • End of study tables and listings review and scientific manuscript drafting/review
  • Reviewing all clinical deliverables, such as final narratives and clinical study reports
  • Providing medical guidance to the internal team and to the trial sites by answering investigator questions about the protocol and the medical management of subject emergencies

Requirements:

  • MD. or equivalent degree with experience in biomedical research and related safety and clinical trials issues
  • Experience working as a physician
  • 2-3 years relevant experience with the design and conduct of clinical research studies, particularly multicenter clinical trials
  • Knowledge of pharmacovigilance, clinical safety regulations and guidelines, and clinical research trials methodology
  • Knowledge of ICH/GCP guidelines
  • Flexibility to travel internationally when needed
  • Ability to communicate effectively with internal and external stakeholders and present findings
  • Ability to independently identify problems and effectively offer solutions to problems
  • Ability to comprehend, integrate and interpret scientific and medical data from a variety of sources
  • Use innovative, creative approaches when necessary, to meet novel needs and/or solve problems
  • Excellent personal integrity, highly organized, efficient, and detail-oriented

To apply for this role, please email your CV and covering letter to susan.yau@blueberrytherapeutics.com


Regulatory Affairs Director

Summary:

The Regulatory Affairs Director provides strategic regulatory affairs guidance, and leads/ oversees Quality Assurance for a number of new clinical stage topical drug formulations to treat dermatological disorders.

Tasks & Responsibilities:

  • Provide strategic regulatory affairs guidance for the development of new topical drug formulations that are in development to treat dermatological disorders
  • Lead regulatory affairs activities with particular focus on regulatory compliance for clinical trials
  • Supervise the Clinical Quality Assurance aspects of the company’s internal and external manufacturing activities
  • Develop or establish relationships with regulatory authorities; industry community and partners in industry as appropriate to Blueberry’s programmes and business plans
  • Identify, select and liaise with external contractors related to regulatory compliant work carried out on behalf of Blueberry and ensure appropriate standards are met
  • To communicate progress and identify risks and issues arising on regulatory issues to the CEO, executive team and clinical teams as appropriate
  • Contribute to a range of project teams, as required
  • Contribute to organising and scheduling teamwork to ensure that projects meet agreed regulatory procedural deadlines
  • Work closely with the Clinical, Manufacturing and Project Management functions to ensure smooth overall clinical development programme execution

Requirements:

  • Bachelor of Science (BSc) with a second degree preferred
  • At least 3 years’ industry/biotech experience in early clinical phase development
  • Proven track record in leading submissions and engagement with UK and EU regulators, and familiarity with US and other international regulatory requirements.
  • Knowledge of Development Good Practices (GxP)
  • Exceptional communication, collaboration, influencing and leadership skills
  • Maintain a high standard of professionalism when representing the Company, both internally and externally
  • Excellent personal integrity, energy and drive

To apply for this role, please email your CV and covering letter to susan.yau@blueberrytherapeutics.com


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Drugs in our pipeline
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Patents and exclusives licences
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Billion dollars in commercial potential

T: 01625 238776 E: info@blueberrytherapeutics.com

Blueberry Therapeutics Ltd Blueberry Therapeutics, Mereside, Alderley Park, Alderley Edge, Cheshire, SK10 4TG.